CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | January 30, 2026 |
| Reported | March 18, 2026 |
| Recalling firm | Beckman Coulter Mishima K.K. |
| Country / region | Japan N/A |
Hazard
A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15 minutes may lead to: Reagent Blank and calibration databases not opening errors: CAL History DB Open Error.., RB History DB Open Error..; system will stop analyzing, firm service must visit to apply software solution; may lead to delay in diagnosis and/or patient treatment
Affected products
- CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281
Related recalls
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